• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SEASPINE INC. MARINER MIS PEDICLE SCREW SYSTEM CORTICAL SHANK, CANNULATED

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SEASPINE INC. MARINER MIS PEDICLE SCREW SYSTEM CORTICAL SHANK, CANNULATED Back to Search Results
Device Problem Fracture (1260)
Patient Problem Failure of Implant (1924)
Event Type  malfunction  
Manufacturer Narrative
No implants were made available for review as the hardware remains in-situ. Additionally, the patient is reported to be fused and asymptomatic. The surgeon plans to monitor the patient for any indication prompting surgical intervention; however, it is not believed to be necessary at this time from a clinical standpoint. Review of the x-ray provided confirms the screw fracture reported. Review of labeling: possible adverse events. Bending, disassembly or fracture of implant and components.
 
Event Description
The patient underwent a 3-level spinal surgery consisting of seaspine's mariner pedicle screw system from level l3-s1. The index surgery date is unknown. Seaspine was made aware on (b)(6) 2020 of a post-operative left s1 screw fracture.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMARINER MIS PEDICLE SCREW SYSTEM
Type of DeviceCORTICAL SHANK, CANNULATED
Manufacturer (Section D)
SEASPINE INC.
5770 armada drive
carlsbad CA 92008
Manufacturer (Section G)
SEASPINE INC.
5770 armada drive
carlsbad CA 92008
Manufacturer Contact
audrey mudderman
5770 armada drive
carlsbad, CA 92008
7602165137
MDR Report Key10908940
MDR Text Key241399833
Report Number3012120772-2020-00089
Device Sequence Number1
Product Code NKB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K191648
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 11/25/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/27/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-